BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMACHOICE III

    MDR report key: 2082173 · Received April 22, 2011

    Report

    Report Number
    2082173
    Event Type
    Malfunction
    Date Received
    April 22, 2011
    Date of Event
    March 23, 2011
    Report Date
    April 22, 2011
    Manufacturer
    ETHICON, INC.
    Product Code
    MKN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A THERMAL DISPOSABLE KIT WAS OPENED AND CONNECTED TO MACHINE. THE WRITING IN WINDOW ON MACHINE STATED HANDPIECE ERROR 5003.THE MACHINE WAS SHUT OFF AND TURNED BACK ON. IT CONTINUED TO STATE ERROR. THE MACHINE WAS AGAIN SHUT OFF, THE DISPOSABLES DISCONNECTED AND REAPPLIED. THE MACHINE WAS TURNED BACK ON BUT IT CONTINUED TO READ ERROR. A NEW THERMAL KIT WAS OPENED AND CONNECTED TO MACHINE WITHOUT PROBLEMS. IT IS NOT KNOWN IF NEW KIT WAS SAME LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMACHOICE III UTERINE ABLATION DEVICE MKN ETHICON, INC. TC003 CJMG04

    Patients

    Seq Age Sex Outcome Treatment
    1 *